Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents

Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

• How to overcome one of the biggest obstacles device manufacturers face
• How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
• How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
• How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

Learning Objectives:

• Understand how to comply with complicated Complaint Handling, MDR and Recall requirements
• Firms MDR reporting and FDA's handling of reports
• Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
• Minimize your risk of regulatory enforcement actions
• Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls
• Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
• Walk-through of case examples
• Step-By-Step guide to designing Standard Operating Systems for communicating process for firm’s success
• Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls

Who Will Benefit:

This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting.

• Regulatory Affairs
• QA/QC
• Project Managers
• Regulatory Professional
• Risk Managers
• Complaint Handling Teams
• CAPA Teams